FDA Grants QIDP, Fast Track Designation To NRx Pharma's NRX-101 To Treat CUTI And Pyelonephritis

(RTTNews) - NRx Pharmaceuticals, Inc. (NRXP) Tuesday said it received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the Food and Drug Administration for NRX-101 for the treatment of complicated urinary tract infections (cUTI) and pyelonephritis.

QIDP and Fast Track designation designation confer particular advantages, including priority review by the FDA, five additional years of data-exclusivity to NRX-101, and rolling submission of the Company's New Drug Application.

The company said that NRX-101 has demonstrated potent activity against resistant urinary pathogens upon FDA review.

"When we embarked on the development of NRX-101 for treating bipolar depression, we did not imagine that it would develop a new utility as a potentially lifesaving antibiotic," said Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals.

NRX-101 is currently in Phase 2b/3 study in suicidal treatment-resistant bipolar depression.